Increasing the Effectiveness of the Diabetes Prevention Program

NCT ID: NCT02008435

Last Updated: 2018-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-12-31

Brief Summary

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The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals (e.g., 7% average loss of body weight), and thereby reducing the risk of developing weight-related health consequences. One-on-one DPP sessions, however, are costly and the group-delivered DPP version, the Group Lifestyle Balance program (GLB), is less effective (4% average loss of body weight). The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, namely if-then plans and their mental practice, into the program. The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems.

Detailed Description

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Please see brief summary.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Enriched GLB

This arm aims to increase the effectiveness of the Group Lifestyle Balance (GLB) program by integrating habit formation techniques, namely if-then plans and their mental practice, into the program.

Group Type EXPERIMENTAL

Enriched GLB

Intervention Type BEHAVIORAL

Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.

Standard GLB

This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.

Group Type ACTIVE_COMPARATOR

Standard GLB

Intervention Type BEHAVIORAL

This arm is the standard Group Lifestyle Balance program

Interventions

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Enriched GLB

Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.

Intervention Type BEHAVIORAL

Standard GLB

This arm is the standard Group Lifestyle Balance program

Intervention Type BEHAVIORAL

Other Intervention Names

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Diabetes Prevention Program weight loss program implementation intentions mental imagery Diabetes Prevention Program weight loss program

Eligibility Criteria

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Inclusion Criteria

* men and women
* ages of 18 and 75
* overweight or obese (BMI 28-45 kg/m2)
* sedentary (\< 200 min/week of moderate or vigorous exercise)
* waist circumference of \>= 88cm for women and \>= 102cm for men

Exclusion Criteria

* diabetes (hemoglobin A1c \< 7.0%).
* taking the medication metformin (used for treating pre-diabetes or diabetes)
* having been pregnant in the past 6 months or planning on becoming pregnant in the next 2 years
* currently undergoing treatment for cancer
* using medication that affects body weight (e.g., loop diuretics)
* being unable to participate in regular moderate physical activity
* having severe uncontrolled hypertension (\> 190/100mm Hg)
* being unable to communicate in English or French
* being diagnosed with bulimia nervosa, currently active major depression, or other severe psychiatric disease (including dementia);
* suffering from a heart attack, stroke, or heart failure within the past 6 months
* experiencing excessive weight loss (more than 10 pounds or 4.54 kilograms) in the past 3 months
* currently participating in another weight loss program
* having had bariatric surgery in the past 2 years or plans on getting it in the near future
* planning on moving away from Montreal within the next year
* having another member of one's household enrolled in the program.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University

OTHER

Sponsor Role lead

Responsible Party

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Barbel Knauper

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbel Knauper, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Ilka Lowensteyn, PhD

Role: STUDY_DIRECTOR

McGill University

Lawrence Joseph, PhD

Role: STUDY_DIRECTOR

McGill University

Aleksandra Luszczynska, PhD

Role: STUDY_DIRECTOR

University of Colorado, Denver

Steven Grover, MD

Role: STUDY_DIRECTOR

McGill University

Locations

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McGill University

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Knauper B, Shireen H, Carriere K, Frayn M, Ivanova E, Xu Z, Lowensteyn I, Sadikaj G, Luszczynska A, Grover S; McGill CHIP Healthy Weight Program Investigators. The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial. Trials. 2020 Jan 7;21(1):40. doi: 10.1186/s13063-019-4014-z.

Reference Type DERIVED
PMID: 31910891 (View on PubMed)

Knauper B, Carriere K, Frayn M, Ivanova E, Xu Z, Ames-Bull A, Islam F, Lowensteyn I, Sadikaj G, Luszczynska A, Grover S; McGill CHIP Healthy Weight Program Investigators. The Effects of If-Then Plans on Weight Loss: Results of the McGill CHIP Healthy Weight Program Randomized Controlled Trial. Obesity (Silver Spring). 2018 Aug;26(8):1285-1295. doi: 10.1002/oby.22226. Epub 2018 Jun 28.

Reference Type DERIVED
PMID: 29956503 (View on PubMed)

Knauper B, Ivanova E, Xu Z, Chamandy M, Lowensteyn I, Joseph L, Luszczynska A, Grover S. Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program. BMC Public Health. 2014 May 18;14:470. doi: 10.1186/1471-2458-14-470.

Reference Type DERIVED
PMID: 24885388 (View on PubMed)

Other Identifiers

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MOP-123242

Identifier Type: -

Identifier Source: org_study_id

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